FDA Device recall Z-0230-2024
Veradius Unity Mobile Surgery C-arm
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Veradius Unity Mobile Surgery C-arm by Philips North America, citing philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Sour….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0230-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-04 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | PR |
Product
Veradius Unity Mobile Surgery C-arm
Reason
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Identifiers
| code_info | Veradius Neo 497 Veradius Neo 607 Veradius Neo 619 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0230-2024%22
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